Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02861950|
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : January 25, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hypospadias Urethrocutaneous Fistula||Drug: Caudal block with ropivacaine Drug: penile nerve block with bupivacaine||Phase 4|
Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:
There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.
The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.|
|Actual Study Start Date :||May 24, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: Caudal block
Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
Drug: Caudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
Active Comparator: Penile Nerve Block
Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.
Drug: penile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine
- Incidence of urethrocutaneous fistula [ Time Frame: 1 year ]Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.
- Degree of efficacy of caudal block [ Time Frame: 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery ]Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed.
- Degree of pain [ Time Frame: 1 hour after arrival in PACU post surgery ]Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU
- Need for supplemental analgesics [ Time Frame: 1 hour after arrival in PACU post surgery ]Administration of opioid in the first postoperative hour will be determined
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|Ages Eligible for Study:||4 Months to 2 Years (Child)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.
- prior hypospadias surgery,
- proximal or penoscrotal hypospadias,
- abnormal caudal anatomy or spinal dysraphism,
- cyanotic congenital heart disease,
- infection or rash at the block injection site.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861950
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Megan Brockel, MD||University of Colorado, Denver|
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
|First Posted:||August 10, 2016 Key Record Dates|
|Last Update Posted:||January 25, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
penile nerve block
Pathological Conditions, Anatomical
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents